MAUDE Adverse Event Report: HILL-ROM INC. XL BARIATRIC BED

Model Number 610B

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2013

Event Type  malfunction  

Event Description

The technician reported the brake caster is broken and will not hold.No pt injury reported.

Manufacturer Narrative

The technician found the wheel was broken off the metal stem of the brake caster.The technician stated the metal stem of the brake caster was left.The bed was at the warehouse.The technician does not know what caused this issue, but assumes it was damaged.The technician replaced the brake caster to resolve the issue.Based on this info, no further action is required.

• Brand Name: XL BARIATRIC BED
• Type of Device: BARIATRIC BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 stat route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3836324
• MDR Text Key: 4408324
• Report Number: 1824206-2014-00190
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 610B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2013
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1